Phase 2
N=41
Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Chronic Aphasia
Aphasia
Bottom Line
View on ClinicalTrials.gov: NCT03651700 ↗Enrolled (actual)
41
Serious AEs
4.9%
Results posted
Sep 2025
Primary outcome: Primary: Change in WAB-AQ — 3.0; 2.8 score on a scale — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Active TMS (Device); Sham TMS (Device); CILT (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- H. Branch Coslett
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in WAB-AQ |
3.0; 2.8 | <.05 sig |
| SECONDARY Change in Percentage of Items Correct on the PNT |
3.4; 3.4 | <.05 sig |
Summary
Transcranial Magnetic Stimulation (TMS) has been demonstrated to improve language function in subjects with chronic aphasia in a number of small studies, many of which did not include a control group. Although the treatment appears promising, data to date do not permit an adequate assessment of the utility of the technique. The investigators propose to study the effects of TMS combined with Constraint Induced Language Therapy (CILT) in 75 subjects with chronic aphasia. Subjects will be randomized in a 2:1 ratio to TMS with CILT or sham TMS with CILT. One Hz TMS at 90% motor threshold will be delivered to the right inferior frontal gyrus for 20 minutes in 10 sessions over 2 weeks; language therapy will be provided for one hour immediately after the conclusion of each session of TMS. Change from baseline in the Western Aphasia Battery Aphasia Quotient at 6 months after the end of TMS treatment will serve as the primary outcome measure.
Eligibility Criteria
Inclusion Criteria
- Clinical evidence and MRI or CT verification of a single left hemisphere stroke with moderate to severe aphasia.
- Suffered their stroke at least 6 months prior to their testing
- Must be able to understand the nature of the study, and give informed consent
Exclusion Criteria
- Multiple strokes (excluding small lacunar strokes) as defined by brain imaging
- History of substance abuse
- Previous head trauma with loss of consciousness for more than 5 minutes
- Psychiatric illness (We note that subjects will be assessed with the 15-item Geriatric Depression scale. Because depression is very difficult to evaluate in aphasic subjects, potential subjects will not be excluded on the basis of the depression score)
- Chronic exposure to medications that might be expected to have lasting consequences for the central nervous system (e.g. haloperidol, dopaminergics)
- History of or neuropsychological findings suggestive of dementia
Data sourced from ClinicalTrials.gov (NCT03651700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.